Effect of tSCS on Ankle Movement Training in Individuals With SCI
NCT ID: NCT06596174
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-11-25
2026-08-31
Brief Summary
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The study aims to:
Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.
Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI.
The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stage 1: Healthy people
Identify optimal tSCS parameters for non-invasive spinal stimulation.
Transcutaneous spinal cord stimulation (tSCS)
The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
Stage 2: SCI Patients
Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.
Short-term Machine-Assisted Ankle Movement Training with tSCS
The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time
Stage 3:SCI Patients
Long-term clinical effects of combined tSCS and ankle movement training
Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS
The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS).
Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.
Stage 3:SCI Patients(Control)
Control Group
No interventions assigned to this group
Interventions
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Transcutaneous spinal cord stimulation (tSCS)
The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
Short-term Machine-Assisted Ankle Movement Training with tSCS
The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time
Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS
The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS).
Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Osteoporosis.
SCI subjects:
1. Current musculoskeletal or joint injuries in the lower limbs.
2. History of central or peripheral neuromuscular diseases.
3. Presence of a pacemaker.
4. Current use of antispastic or antidepressant medications.
5. Current venous thromboembolism or osteoporosis.
6. Impairment of the soleus H-reflex arc.
20 Years
ALL
Yes
Sponsors
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Chang Gung University
OTHER
Responsible Party
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Ya-Ju Chang
Professor
Locations
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Chang Gung University
Taoyuan District, , Taiwan
Countries
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Facility Contacts
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Other Identifiers
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SCI_001
Identifier Type: -
Identifier Source: org_study_id
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